Methods of treating fragile X associated disorders, ADHD, and autism spectrum disorder

Abstract

Provided are novel methods comprising administering a therapeutically effective amount of (1R,5S)-1-(naphthalen-2-yl)-3-azabicyclo[3.1.0]hexane, in free or pharmaceutically acceptable salt form, to a patient in need thereof.

Description

CROSS REFERENCE TO RELATED APPLICATIONS[0001]This application is the National Stage Entry under 35 U.S.C. §371 of International Application No. PCT / US2014 / 069401 filed Dec. 9, 2014, which claims priority to U.S. Provisional Application No. 61 / 913,886 filed Dec. 9, 2013, the contents of both of which are hereby incorporated by reference.BACKGROUND[0002]Fragile X-associated disorders are a family of genetic conditions that may affect individuals in a variety of ways. The three fragile X-associated disorders are fragile X syndrome (FXS), fragile X-associated tremor / ataxia syndrome (FXTAS), and fragile X-associated primary ovarian insufficiency (FXPOI). The conditions are all caused by changes in the fragile X mental retardation 1 (FMR1) gene, located on the X chromosome. In most people, the FMR1 gene contains approximately 5-44 repeats of the cytosine guanine guanine (CGG) trinucleotide within the 5′ untranslated region.[0003]Fragile X syndrome (FXS) is the most common inherited form o...

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Affected women may exhibit intermittent and unpredictable menses, with eventual early cessation.

However, concerns about stimulants include risk of abuse, dependency, and diversion as well as potential neurotoxic effects of amphetamines.

It has been reported, however, that some individuals with FXS failed treatment predominately due to aggravation of aggressive, perseverative, and irritable behavior.

Six trials of atomoxetine in individuals with FXS, however, were unsuccessful, with the majority failing due to aggravation of irritable, moody, and aggressive behaviors.

However, as discussed above, concerns about treatment with stimulants include risk of abuse, dependency, and diversion as well as potential neurotoxic effects of amphetamines.

In addition, stimulants may exacerbate anxiety.

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